Sr Document Control Administrator

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

How Will You Make an Impact?

Join Thermo Fisher Scientific as a Sr. Document Control Administrator, supporting R&D,  QA & the Manufacturing teams with efficient documentation processes.

A Day in the Life:

• Complete document-related tasks with strict attention to detail, ensuring accurate execution on the first try. Tasks include optimizing documents, printing, regular review, withdrawal, reconciliation, issuance, archiving, scanning, record retention, off-site shipment and retrieval, document release, and audits.
• Document all activities in accordance with cGMP requirements to maintain our high standards of compliance.
• Follow all safety procedures, including the use of Personal Protective Equipment, as needed, to ensure a safe working environment.
• Revise batch records and ensure they align with good documentation practices.
• Build and update essential documents like SOPs, forms, work instructions, and visual aids to support our teams.
• Efficiently manage document change orders using Oracle (OCPLM) and support the change management system.
• Lead and plan Change Control Meetings, successfully monitoring changes to meet project goals.
• Provide new part numbers per part request form and enter material numbers in SAP.
• Assign and manage numbers for Engineering Change Requests, Engineering Change Orders, and Waivers.
• Review and process ECRs using an electronic routing system, and ECOs via SAP.
• Maintain a comprehensive electronic documentation database for all engineering changes and waivers.
• Train and support staff and colleagues, encouraging a culture of continuous learning and improvement.
• Coordinate the generation of Certificates of Compliance to meet regulatory standards.
• Engage in various activities, including safety inspections, improvement projects, and other documentation processes.
• Participate actively in shift exchanges, one-on-one meetings, team building exercises, and both internal and external audits as required.

Education:

Bachelor’s degree in science, computer science, business administration, or a similar field is required, or equivalent experience.

Experience:

• A minimum of two (2) years of experience in a regulated environment.
• Familiarity with good manufacturing and documentation practices is essential.

Knowledge, Skills, Abilities:

• Must be fully bilingual in Spanish and English.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Experience with SAP, ADOBE, Solid Works, and CodeSoft Labeling Software is helpful.
• Ability to effectively multi-task and communicate clearly.
• High ethical standards are crucial; quality requirements must not be compromised.

Physical Requirements / Work Environment

The role requires basic physical activities such as walking, standing, and bending, along with the ability to lift and carry light to medium weights. Good hand and finger dexterity for typing and clear vision for computer use and reading are necessary.

Benefits

Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization. We provide an exciting company culture that stands for integrity, intensity, involvement, and innovation. Our mission is to enable our customers to make the world healthier, cleaner, and safer.

What We Offer

• Competitive remuneration
• Annual incentive plan bonus
• Annual merit performance-based increase
• Medical, Dental, & Vision benefits-effective Day 1
• Paid Time Off & Designated Paid Holidays
• 401K